What is pembrolizumab studying for metastatic non-squamous lung cancer?

Pembrolizumab is being studied to compare two different schedules of maintenance treatment in patients with metastatic non-squamous lung cancer. The trial evaluates whether giving pembrolizumab less frequently is as effective as the usual dosing schedule. The study is led by Gustave Roussy, Cancer Campus, Grand Paris.

Who may be eligible for this metastatic non-squamous lung cancer clinical trial?

Adults aged 18 or older with a confirmed diagnosis of non-squamous non-small cell lung cancer may be eligible. Participants should have received 3 or 4 cycles of induction treatment with pembrolizumab plus platinum and pemetrexed, and have a good performance status. Please review eligibility criteria for more details.

Is there any cost to participate in this metastatic non-squamous lung cancer clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses and other costs related to attending study visits may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID05692999

Maintenance Pembrolizumab at Usual or Low Dose in Non-squamous Lung Cancer a Non-inferiority Study

Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2025-06-25

1166

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying a new way to give immunotherapy as maintenance treatment for patients with metastatic non-squamous lung cancer. This phase III clinical trial compares a pulse dosing schedule with a conventional dosing schedule to see if the less frequent pulse dosing is not worse than the standard treatment. The study focuses on pembrolizumab alone or combined with pemetrexed as the maintenance therapy after initial chemotherapy and immunotherapy induction. Participants are randomly assigned to one of two groups. In the Pulse arm, pembrolizumab 200 mg is given every 6 weeks, and pemetrexed 500 mgm is given every 3 weeks if there is no contraindication. In the Control arm, pembrolizumab is given either 200 mg every 3 weeks or 400 mg every 6 weeks, plus pemetrexed 500 mgm every 3 weeks when appropriate. This treatment is given after patients have completed 3 or 4 cycles of induction therapy with pembrolizumab plus platinum and pemetrexed. During the study, participants will be monitored for overall survival over 6 years, along with progression-free survival, response duration, quality of life using several questionnaires, treatment tolerance, and economic factors. Researchers will also perform population pharmacokinetic analyses and study the drugs effect on immune cells. Patients will undergo regular assessments including clinical evaluations and laboratory tests to track treatment effects and safety throughout the study period.

CONDITIONS

Brief Title

Maintenance Pembrolizumab at Usual or Low doSE in Non-squamous Lung Cancer: a Non-inferiority Study

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Histologically or cytologically confirmed diagnosis of non-squamous non-small cell lung cancer (NSCLC).
Non-operable or non-irradiable stage III or stage IV disease.
Eligible to receive 3 or 4 cycles of induction treatment with pembrolizumab plus platinum and pemetrexed.
For patients with EGFR mutation, ALK or ROS1 rearrangement, at least one specific targeted therapy line received.
Age 18 years or older.
Performance status of 0 or 1.
Signed informed consent.
Affiliated to a social security system or beneficiary of the same.
Last induction chemotherapy cycle within 42 days before randomization.
Stable disease, partial or complete response according to RECIST 1.1 after induction.
Creatinine clearance >30 ml/min if maintenance with pembrolizumab alone; >45 ml/min if pemetrexed plus pembrolizumab.
Neutrophils ≥ 1500/µL and platelets ≥ 100,000/µL.
Bilirubin ≤ 1.5 times upper limit normal.
Transaminases and alkaline phosphatase ≤ 2.5 times upper limit normal or 5 times if liver metastases.
Previous platinum-based chemotherapy or immune checkpoint inhibitors allowed under specified conditions.
Women must be non-childbearing or use effective contraception; men must use condoms during and after study medication.

You will not qualify if you...

Mixed small-cell or squamous-cell carcinoma.
Mental or psychological illness preventing informed consent.
Pregnant or breastfeeding women.
History of HIV or chronic hepatitis B or C.
Active or uncontrolled infection.
Recent serious cardiovascular disorders within 6 months.
Concomitant participation in another clinical trial or treatment with experimental drugs.
Grade 3 or 4 toxicity from pembrolizumab limiting maintenance treatment.
Use of corticosteroids above 20 mg prednisone or equivalent.
Ongoing immunosuppressive systemic therapy.
Active autoimmune diseases or related conditions, except stable hypothyroidism or insulin-treated diabetes.
History of severe lung diseases or active pneumonia.
History of other malignancies unless in remission for at least 2 years.
Administration of live attenuated vaccines within 4 weeks before study start or planned during the study.
Conditions making study participation unsafe or inappropriate.

Research Team

Benjamin BESSE

Lynda MATI

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